ppMira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company. /p pMira’s breakthrough innovation was creating the market’s only FDA-compliant at-home hormone monitor with quantitative testing technology. From the beginning, our mission has been to make hormone data accessible and meaningful - so women can understand their bodies and make confident health decisions at every stage of life, from cycle health and family planning to hormonal imbalances and the menopause transition. /p pWe are committed to improving real health outcomes through personalized insights, cutting-edge technology, and science-backed data—turning hormone information into practical guidance for everyday wellbeing. /p h3About the position /h3 pWe are looking for a bRegulatory Submission Specialist /b to lead and support the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices. The role will ensure that clinical, analytical, usability, risk-management, quality, and labelling evidence is compiled into clear, submission-ready technical documentation and supports regulatory compliance throughout the product lifecycle. /p pThe ideal candidate has experience in bregulatory submissions /b, btechnical documentation and clinical-performance evidence /b, and binternational IVD regulatory requirements /b. /p h3Responsibilities /h3 ul liPrepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation. /li liReview intended-use statements, product claims, instructions for use, labelling, advertising materials, and product specifications for regulatory alignment. /li liAssess analytical, clinical-performance, usability, stability, software, and risk-management evidence to confirm it supports the device’s intended purpose and claims.



/li liCoordinate evidence collection from internal teams, manufacturers, clinical research organisations, laboratories, quality teams, and external regulatory consultants. /li liIdentify evidence gaps and develop regulatory evidence plans, including requirements for analytical studies, clinical performance studies, and lay-user/self-test studies. /li liSupport the preparation and review of clinical-performance documentation, including study protocols, performance evaluation reports, statistical summaries, and reference-method justifications. /li liPrepare responses to regulatory authority questions, requests for information, and audit-related documentation. /li liMaintain regulatory intelligence on applicable IVD regulations, standards, guidance, and market requirements. /li liSupport post-market regulatory activities, including change assessments, vigilance/adverse-event reporting, recalls, corrective actions, and periodic documentation updates. /li liPartner with Quality, RD, Clinical, Product, and Commercial teams to ensure products remain compliant throughout their lifecycle. /li /ul h3Requirements /h3 ul liBachelor degree in bRegulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or a related discipline /b. /li li2+ years of experience in bregulatory affairs for medical devices or in vitro diagnostic devices /b, including preparation of technical documentation or regulatory submissions. /li liExperience supporting or preparing bCE-marking documentation under the EU IVDR (Regulation (EU) 2017/746) /b,



including technical documentation and performance evaluation requirements. /li liWorking knowledge of IVD quality and regulatory frameworks, including ISO 13485, ISO 14971, ISO 20916, and applicable post-market surveillance and vigilance requirements. /li liExperience reviewing or preparing analytical-performance and clinical-performance documentation for IVDs, including sensitivity, specificity, precision, reproducibility, interference, stability, and method-comparison studies. /li liFamiliarity with relevant IVD standards and guidance, including CLSI EP guidelines; experience with self-tests or consumer-use IVDs is highly desirable. /li liExcellent technical writing, document-control, project-management, and stakeholder-coordination skills, with the ability to work independently in a fast-paced startup environment. /li /ul h3Details /h3 pThe role is a remote position, with a 40-hour workweek, flexible working hours, and occasional overlap with the US team. /p h3What we offer /h3 ul liJoin one of the fastest-growing femtech companies in the U.S., driven by a strong mission to advance women’s health and expand access to care /li liBe part of a passionate, highly motivated, and international team dedicated to making a real difference in people’s lives /li liThrive in a fast-paced startup environment where your work directly impacts company growth, strategy, and key decisions /li liEnjoy real opportunities for career growth, with the ability to shape, build, and develop teams as we scale /li liWork in a flexible, fully remote environment that supports autonomy, ownership, and independence /li liReceive a competitive salary along with a performance-based premio system tied to OKRs /li /ul pStep 1 ‘Screening call with HR’ - Step 2 ‘Assessment task’ - Step 3 ‘Interview with Director of Regulatory and Quality’ - Step 4 - ‘Cultural Interview’ /p /p #J-18808-Ljbffr

📌 Regulatory Submission Specialist (Eu Ivdr / Ce-Mark) (Italia)
🏢 MIRA
📍 Italia